Increase Safety Case Management Efficiency by Integrating with Leading Safety Systems
Case assignment in safety systems is basically a manual job making it very tedious for the workflow manager to assign cases to individuals. This challenge of case assignment is particularly accentuated in a scenario of globally dispersed teams. Based on the case count and team availability, the workflow manager has to perform a periodic reconciliation of cases’ statuses and then start the process of assigning and re-assigning the cases to ensure their speedy processing.
Managers find it extremely difficult to obtain an overview of their team’s productivity and efficiency as there is a lack of insights to help them make their decisions. There is an absence of informative dashboards in the safety systems which are in use.
Gaining an overview of the team performance becomes even more complicated when Pharma companies have more than one MAH configured as different tenants in a single safety system or in multiple ones and when a Service Provider is processing cases for multiple Pharma companies on multiple safety databases.
Communication Challenges: Effective communication is essential for successful pharmacovigilance case management, and this can be difficult when dealing with multiple MAHs and safety systems. There may be differences in terminology and processes between the different systems, leading to confusion and delays in case management.
Resource Allocation: Having multiple MAHs and safety systems can place a significant burden on resources, including staff, budget, and IT infrastructure. Allocating resources to manage cases across multiple systems can be challenging, and it may be necessary to prioritize cases based on their potential impact on patient safety.
Introducing Compier ICSR Management
Compier ICSR Operations provides digitalization and automation of case assignment along with insights on the case and user progress. Cases can be auto assigned to users thereby reducing the manual work of a workflow manager. Managers are provided with complete insights of the case processing business workflow. They are given information on different insights such as case details, user details and the details of the time taken to process the case. This information helps them assess their team’s productivity and efficiency.
Solution Features & Benefits
- Eliminate lengthy, redundant and error-prone process in assigning safety cases to global PV team members
- Managers can perform periodic reconciliation of cases’ statuses and re-assign cases for speedy processing
- WIth Compier, decision makers can assess their team’s productivity and efficiency with operational insights
- Simplify the overall case processing effort when Pharma companies have more than one MAH configured
- Gain visibility on case processing outcomes with connected communication and historical tracking
- Stay informed on reporting delays and other issues that could result as findings during audits and inspections
Compier PV Ops – Quality Assurance
Quality assurance of ICSRs is critical to ensure regulatory compliance, patient safety, and data integrity. However, manual QA processes are fraught with inefficiencies and risks that impact both operational performance and audit readiness. Our digital and automated QA solution revolutionizes how pharmacovigilance teams manage compliance and efficiency. Instead of replacing human oversight, AI augments human reviewers by automating routine checks and flagging potential errors in real time.
Salient Features:
- Prospective QA: Review ICSRs in a compliant way and report outcomes before regulatory submissions
- Retrospective QA: Review Archived ICSRs retrospectively for correctness and completeness
- Scheduling: Schedule and Assign ICSRs to users for review with notifications
- Randomization: Perform Reviews on all ICSRs or randomly picked based on sampling sizes
- Review Form: Define Review Forms along with criticality and scoring based on organization needs
- Correspondence: Share the completed review reports for ICSRs with review outcome
- Dashboard Insights: Track overall Quality Compliance of ICSRS based on users, error types and criticality
Benefits
- Increased Accuracy: Ensures consistent application of QA rules, reducing manual errors in coding, completeness, and regulatory field validation.
- Faster Turnaround Times: Automated QA checks dramatically reduce review cycle times, enabling quicker case closure and timely regulatory submissions.
- Enhanced Scalability: Easily scale QA operations to handle surges in case volume without proportionally increasing resources.
- Standardization of Review: AI enforces uniform QA criteria, reducing subjectivity and variability across reviewers.
- Real-Time Error Detection: Intelligent algorithms can flag missing data, inconsistencies, or non-compliance as cases are processed.
- Audit-Ready Traceability: Automated QA systems provide detailed logs, decision trails, and justifications to support inspections and audits.
- Freeing Up Expert Time: Automation of low-value, repetitive QA tasks allows experts to focus on complex cases, signal analysis, and continuous improvement.
Solution FAQs
We offer the Compier ICSR Management solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier ISCR Ops Management system along with the required system integrations.
Compier ICSR Management is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.
Our subject matter experts will deliver a hands-on Compier ICSR Management application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations.
The Compier ICSR Management solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity.
The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions.
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